Vitamin D DeficiencyNCT05937789
Early Vitamin D3 Supplementation for Critically Ill Patients
A study testing Vitamin D3 and Medium Chain Triglycerides (MCT) in people with Vitamin D Deficiency and Critical Illness, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
There are no clear international guidelines for dosing vitamin D based on deficiency severity. Therefore, a new clinical trial is needed to evaluate the benefits of early vitamin D supplementation in maintaining sufficient levels for critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D Deficiency, Critical Illness
- What is being tested?
- Vitamin D3 and Medium Chain Triglycerides (MCT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Jan 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18-year-old critically ill patient.
- ICU admission < 24 hours.
- Baseline 25(OH)D levels within 24 hours of ICU admission < 20 ng/mL.
- Expected ICU length of stay ≥ 72 hours.
Who cannot join
- Hypercalcemia (ie. total serum calcium levels > 2.6 mmol/L).
- Disorders affecting serum 25(OH)D levels, calcium metabolism, or bone metabolism (eg, parathyroid disease, rickets, or severe cirrhosis [Child C]).
- Having received high-dose vitamin D3 therapy (ie. > 2,000 IU daily or a single dose of ≥ 10,000 IU) within the past four weeks.
- Active COVID-19 at ICU admission.
- Organ transplant.
- Having had tuberculosis, sarcoidosis or kidney stones within the past year.
Show all 10Show fewer
- Having renal dialysis, continuous kidney replacement therapy (CKRT), acute kidney injury (AKI).
- Having ICU admission within the past three months.
- Non-native-speaking patients and their families
- Pregnant women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Yin-Yi Han, doctor, 886972651405, noviahan@gmail.com
About this study
Official title: Effects of Early Vitamin D3 Supplementation on Clinical Outcomes for Critically Ill Patients
There are no clear international guidelines for dosing vitamin D based on deficiency severity. Therefore, a new clinical trial is needed to evaluate the benefits of early vitamin D supplementation in maintaining sufficient levels for critically ill patients. The investigators conducted a multicenter clinical trial in Taiwan focusing on vitamin D and critically ill patients. 240 patients with low calcidiol levels will be enrolled and be provided varying supplementation doses to maintain their serum calcidiol levels ≥ 30 ng/mL within 30 days of ICU admission. The serum levels of calcidiol and PTH will be measured on Day 0, Day 7, Day 14 and Day 30 before and after vitamin D supplementation. The results will serve as a valuable reference for intensivists when formulating appropriate vitamin D treatment strategy to maximize clinical benefits for critically ill patients.
Read the detailed description
Recent studies have highlighted a prevalent vitamin D deficiency in critically ill patients, ranging from 26% to 82%. These patients experience longer ICU stays, higher medical expenses, and increased sepsis-related mortality. The investigators conducted a multicenter clinical trial in Taiwan focusing on vitamin D and critically ill patients. In the first phase, the epidemiological investigation found significantly lower serum calcidiol levels of approximately 20.9 ng/mL compared to the normal range of 30-60 ng/mL in ICU patients. The second phase, a randomized control study, preliminarily demonstrated that supplementing 576,000 IU of vitamin D3 in critically ill patients with serum calcidiol levels below 20 ng/mL significantly reduced the risk of multidrug resistant bacterial infections within 30 days. An Austrian trial also showed that adequate vitamin D supplementation lowered in-hospital mortality in severely deficient patients. The importance of vitamin D supplementation for critically ill patients with vitamin D deficiency is evident, as their clinical prognosis is closely related to achieving adequate serum calcidiol levels. However, there are no clear international guidelines for dosing vitamin D based on deficiency severity. Therefore, a new clinical trial is needed to evaluate the benefits of early vitamin D supplementation in maintaining sufficient levels for critically ill patients. The investigators will enroll 240 patients with low calcidiol levels and provide varying supplementation doses to maintain their serum calcidiol levels ≥ 30 ng/mL within 30 days of ICU admission. The serum levels of calcidiol and PTH will be measured on Day 0, Day 7, Day 14 and Day 30 before and after vitamin D supplementation. The results will serve as a valuable reference for intensivists when formulating appropriate vitamin D treatment strategy to maximize clinical benefits for critically ill patients.
- Conditions
- Vitamin D Deficiency, Critical Illness
- Being tested
- Vitamin D3, Medium Chain Triglycerides (MCT)
- Keywords
- vitamin D, calcidiol levels, critically ill
- Medical subject headings
- Vitamin D Deficiency, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Dose of vitamin D3 depends on participant's serum 25(OH)D levels, with one sample bottle contains 72,000 IU of vitamin D3; Intervention starts on ICU day 3 with a frequency of 1 ampule every 3 hours and is completed within the following 48 hours
Medium Chain Triglycerides (MCT)Dietary supplement
Dose of MCT depends on participant's serum 25(OH)D levels, with one sample bottle contains 5 cc. of MCT; Intervention starts on ICU day 3 with a frequency of 1 ampule every 3 hours and is completed within the following 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Control1 | Placebo comparator | Participants with serum 25(OH)D levels of 15-19.9 ng/mL, receiving 40 cc. medium-chain triglyceride (MCT) supplement. Receives: Dietary Supplement: Medium Chain Triglycerides (MCT) |
| Control2 | Placebo comparator | Participants with serum 25(OH)D levels of 12-14.9 ng/mL, receiving 50 cc. MCT supplement. Receives: Dietary Supplement: Medium Chain Triglycerides (MCT) |
| Control3 | Placebo comparator | Participants with serum 25(OH)D levels below 12 ng/mL, receiving 60 cc. MCT supplement. Receives: Dietary Supplement: Medium Chain Triglycerides (MCT) |
| Vitamin D1 | Experimental | Participants with serum 25(OH)D levels of 15-19.9 ng/mL, receiving vitamin D3 of 576,000 IU supplement Receives: Dietary Supplement: Vitamin D3 |
| Vitamin D2 | Experimental | Participants with serum 25(OH)D levels of 12-14.9 ng/mL, receiving vitamin D3 of 720,000 IU supplement Receives: Dietary Supplement: Vitamin D3 |
| Vitamin D3 | Experimental | Participants with serum 25(OH)D levels below 12 ng/mL, receiving vitamin D3 of 864,000 IU supplement Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality rate
30-day mortality rate after intervention with the study samples.
Measured: 30 days
Secondary outcomes (7)
30-day mortality rate of patients who survives >7 days
30-day mortality rate of patients who survives >7 days after intervention with the study. samples
Measured: 30 days
Length of ICU stay for surviving patients
Length of ICU stay for surviving patients.
Measured: 30 days
Length of hospital stay for surviving patients
Length of hospital stay for surviving patients.
Measured: 30 days
30-day mortality based on serum 25(OH)D levels on day 7
Comparison of 30-day mortality between the two treatment groups based on serum 25(OH)D levels on day 7: ≥ 30 ng/mL vs. < 30 ng/mL.
Measured: 30 days
30-day mortality based on serum 25(OH)D levels on day 30
Comparison of 30-day mortality between the two treatment groups based on serum 25(OH)D levels on day 30: ≥ 30 ng/mL vs. < 30 ng/mL.
Measured: 30 days
30-day mortality based on APACHE II scores at ICU 24 hours
Comparison of 30-day mortality between the three groups based on 24-hour APACHE II scores: <20, 20-39, and ≥39.
Measured: 30 days
Correlation of 25(OH)D increment after vitamin D supplement and body weight
Correlation between 25(OH)D levels and body weight on day 7 after supplementation in the treatment group.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start22 Jan 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937789
- Sponsor's protocol ID
- 202305074RIPC
- Status last verified
- Jul 2024
- First submitted
- 30 Jun 2023
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Vitamin D3 Supplementation on Clinical Outcomes for Critically Ill Patients
- ClinicalTrials.gov ID
- NCT05937789
- Acronym / sponsor ID
- 202305074RIPC
- Conditions
- Vitamin D Deficiency, Critical Illness
- Keywords
- vitamin D, calcidiol levels, critically ill
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are no clear international guidelines for dosing vitamin D based on deficiency severity. Therefore, a new clinical trial is needed to evaluate the benefits of early vitamin D supplementation in maintaining sufficient levels for critically ill patients. The investigators conducted a multicenter clinical trial in Taiwan focusing on vitamin D and critically ill patients. 240 patients with low calcidiol levels will be enrolled and be provided varying supplementation doses to maintain their serum calcidiol levels ≥ 30 ng/mL within 30 days of ICU admission. The serum levels of calcidiol and PTH will be measured on Day 0, Day 7, Day 14 and Day 30 before and after vitamin D supplementation. The results will serve as a valuable reference for intensivists when formulating appropriate vitamin D treatment strategy to maximize clinical benefits for critically ill patients.
Detailed description
Recent studies have highlighted a prevalent vitamin D deficiency in critically ill patients, ranging from 26% to 82%. These patients experience longer ICU stays, higher medical expenses, and increased sepsis-related mortality. The investigators conducted a multicenter clinical trial in Taiwan focusing on vitamin D and critically ill patients. In the first phase, the epidemiological investigation found significantly lower serum calcidiol levels of approximately 20.9 ng/mL compared to the normal range of 30-60 ng/mL in ICU patients. The second phase, a randomized control study, preliminarily demonstrated that supplementing 576,000 IU of vitamin D3 in critically ill patients with serum calcidiol levels below 20 ng/mL significantly reduced the risk of multidrug resistant bacterial infections within 30 days. An Austrian trial also showed that adequate vitamin D supplementation lowered in-hospital mortality in severely deficient patients. The importance of vitamin D supplementation for critically ill patients with vitamin D deficiency is evident, as their clinical prognosis is closely related to achieving adequate serum calcidiol levels. However, there are no clear international guidelines for dosing vitamin D based on deficiency severity. Therefore, a new clinical trial is needed to evaluate the benefits of early vitamin D supplementation in maintaining sufficient levels for critically ill patients. The investigators will enroll 240 patients with low calcidiol levels and provide varying supplementation doses to maintain their serum calcidiol levels ≥ 30 ng/mL within 30 days of ICU admission. The serum levels of calcidiol and PTH will be measured on Day 0, Day 7, Day 14 and Day 30 before and after vitamin D supplementation. The results will serve as a valuable reference for intensivists when formulating appropriate vitamin D treatment strategy to maximize clinical benefits for critically ill patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control1 | Placebo comparator | Dietary Supplement: Medium Chain Triglycerides (MCT)Participants with serum 25(OH)D levels of 15-19.9 ng/mL, receiving 40 cc. medium-chain triglyceride (MCT) supplement. |
| Control2 | Placebo comparator | Dietary Supplement: Medium Chain Triglycerides (MCT)Participants with serum 25(OH)D levels of 12-14.9 ng/mL, receiving 50 cc. MCT supplement. |
| Control3 | Placebo comparator | Dietary Supplement: Medium Chain Triglycerides (MCT)Participants with serum 25(OH)D levels below 12 ng/mL, receiving 60 cc. MCT supplement. |
| Vitamin D1 | Experimental | Dietary Supplement: Vitamin D3Participants with serum 25(OH)D levels of 15-19.9 ng/mL, receiving vitamin D3 of 576,000 IU supplement |
| Vitamin D2 | Experimental | Dietary Supplement: Vitamin D3Participants with serum 25(OH)D levels of 12-14.9 ng/mL, receiving vitamin D3 of 720,000 IU supplement |
| Vitamin D3 | Experimental | Dietary Supplement: Vitamin D3Participants with serum 25(OH)D levels below 12 ng/mL, receiving vitamin D3 of 864,000 IU supplement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18-year-old critically ill patient.
- ICU admission < 24 hours.
- Baseline 25(OH)D levels within 24 hours of ICU admission < 20 ng/mL.
- Expected ICU length of stay ≥ 72 hours.
Key exclusion criteria (10 listed)
- Hypercalcemia (ie. total serum calcium levels > 2.6 mmol/L).
- Disorders affecting serum 25(OH)D levels, calcium metabolism, or bone metabolism (eg, parathyroid disease, rickets, or severe cirrhosis [Child C]).
- Having received high-dose vitamin D3 therapy (ie. > 2,000 IU daily or a single dose of ≥ 10,000 IU) within the past four weeks.
- Active COVID-19 at ICU admission.
- Organ transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Dose of vitamin D3 depends on participant's serum 25(OH)D levels, with one sample bottle contains 72,000 IU of vitamin D3; Intervention starts on ICU day 3 with a frequency of 1 ampule every 3 hours and is completed within the following 48 hours | Dietary supplement | Vitamin D1, Vitamin D2, Vitamin D3 |
| Medium Chain Triglycerides (MCT)Dose of MCT depends on participant's serum 25(OH)D levels, with one sample bottle contains 5 cc. of MCT; Intervention starts on ICU day 3 with a frequency of 1 ampule every 3 hours and is completed within the following 48 hours | Dietary supplement | Control1, Control2, Control3 |
Primary outcome
30-day mortality rate
Time frame: 30 days
30-day mortality rate after intervention with the study samples.
7 secondary outcomes
30-day mortality rate of patients who survives >7 days
Time frame: 30 days
Length of ICU stay for surviving patients
Time frame: 30 days
Length of hospital stay for surviving patients
Time frame: 30 days
30-day mortality based on serum 25(OH)D levels on day 7
Time frame: 30 days
30-day mortality based on serum 25(OH)D levels on day 30
Time frame: 30 days
30-day mortality based on APACHE II scores at ICU 24 hours
Time frame: 30 days
Correlation of 25(OH)D increment after vitamin D supplement and body weight
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 and Medium Chain Triglycerides (MCT) in people with Vitamin D Deficiency and Critical Illness, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yin Yi Han, doctor (886972651405, noviahan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.